GE Healthcare Recalls Giraffe OmniBed Infant Warmers Due to Latch Defect
GE Healthcare is recalling Giraffe OmniBed infant warmers because bedside panels and portholes may appear closed without being latched, posing a risk of patient falls.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class I recall, which mandates a minimum severity score of 4 per the rubric. The hazard involves a structural defect leading to a potential patient fall, which aligns with the criteria for severe injury risk.
Plain-English summary
GE Healthcare, LLC is recalling 23,693 units of the Giraffe OmniBed infant warmer. The recall is due to a defect where bedside panels and portholes can appear closed without being latched. This issue creates a potential risk of patient falls.
The affected units were distributed worldwide. The recall covers specific model numbers, including 6650-0XXX-XXX, 2074920-00X-XXXXXX, and various M-series models. An update dated June 3, 2021, indicates that all model numbers and units are affected.
Healthcare facilities should stop using the affected devices and contact GE Healthcare for instructions on repair or replacement. The U.S. Food and Drug Administration has classified this as a Class I recall.
The recalled product
- Product
- Giraffe OmniBed infant warmer
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Infant Warmer
- Affected units
- 23,693
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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